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Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: June 15, 2018

Posted 2 days ago in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: First Generic Under-the-Tongue Opioid Addiction Treatment Approved by FDA The first generic version of an under-the-tongue film to treat opioid addiction has been approved by the U.S. Food and Drug Administration. The generic version of Suboxone (buprenorphine and naloxone) film from Mylan Technologies Inc. and... Read more

Healthful Grilling Is as Simple as 1, 2, 3, 4

Posted today in Medical

SUNDAY, June 17, 2018 -- While some might be wary about the cancer risks of searing a steak on a flaming grill, a few simple changes can lower that risk, a nutritionist advises. Cooking beef, pork, fish or poultry over high temperatures can lead to the formation of chemicals that can trigger changes in your DNA that increase the risk of cancer. "It might seem like everything fun causes cancer," said Catherine... Read more

Beach, Boating and Booze Add Up to Summer Injuries

Posted yesterday in Medical

SATURDAY, June 16, 2018 -- You'd better think twice before taking booze to the beach or out on a boat. Alcohol increases the risk of injury and death in and on the water, safety experts warn. For example, alcohol is a factor in up to 70 percent of all water recreation deaths of teens and adults, according to the U.S. National Institute on Alcohol Abuse & Alcoholism (NIAAA). Drinking impairs judgment and makes... Read more

Portable Music Player Use Linked to Hearing Loss in Children

Posted 2 days ago in News for Health Professionals

FRIDAY, June 15, 2018 -- Portable music player (PMP) use may be associated with high-frequency hearing loss in children, according to a study published online June 14 in JAMA Otolaryngology-Head & Neck Surgery. Carlijn M.P. le Clercq, M.D., from the Erasmus University Medical Center in the Netherlands, and colleagues conducted a cross-sectional study within an ongoing prospective birth cohort study. A total of... Read more

Doctors Want Substantial Improvements in EHRs

Posted 2 days ago in News for Health Professionals

FRIDAY, June 15, 2018 -- Although primary care physicians (PCPs) see value in electronic health records (EHRs), they want substantial improvements, and generally agree on what these improvements should be, according to research from Stanford Medicine, conducted with The Harris Poll. Researchers examined perceptions of EHR systems among PCPs, focusing on identifying what problems PCPs encounter with EHRs. A total of... Read more

Kellogg's Honey Smacks Cereal Recalled Due to Salmonella Risk

Posted 2 days ago in News for Health Professionals

FRIDAY, June 15, 2018 -- The Kellogg Company has announced it is recalling certain boxes of Honey Smacks cereal due to the possibility of contamination with Salmonella. According to the U.S. Centers for Disease Control and Prevention, 73 illnesses potentially tied to contaminated cereal have been reported across 31 states. Twenty-four people have been hospitalized, but no deaths have been reported. Illnesses have... Read more

Resistant A. Baumannii Rose in Children From 1999 to 2012

Posted 2 days ago in News for Health Professionals

FRIDAY, June 15, 2018 -- Between 1999 and 2012, Acinetobacter baumannii (A. baumannii) antibiotic resistance increased in children, though there was a decreasing trend after 2008, according to a study published in the Journal of the Pediatric Infectious Diseases Society. Latania K. Logan, M.D., from the Rush University Medical Center in Chicago, and colleagues used antimicrobial susceptibility data from The... Read more

FDA Approves First Generic Under-the-Tongue Suboxone

Posted 2 days ago in News for Health Professionals

FRIDAY, June 15, 2018 -- The first generic version of an under-the-tongue film to treat opioid addiction has been approved by the U.S. Food and Drug Administration. The generic version of Suboxone (buprenorphine and naloxone) film from Mylan Technologies Inc. and Dr. Reddy's Laboratories SA will be available in different strengths. The brand name and generic films should be used as part of an overall treatment plan... Read more

The Hot Dog You Shouldn't Have

Posted 2 days ago in Medical

FRIDAY, June 15, 2018 -- The scorching heat of summer poses dangers to people, but dogs also need protection from soaring temperatures, one veterinarian warns. Benjamin Brainard, director of clinical research at the University of Georgia's College of Veterinary Medicine, offered the following tips to help pet owners keep their dogs cool when it heats up outside: Never leave dogs in the car. Never leave a dog... Read more

Exercise May Counter Effects of Obesity Genes

Posted 2 days ago in Medical

FRIDAY, June 15, 2018 -- Older women who carry genes that make them prone to obesity may take comfort in new findings that suggest exercise can counter that risk. For the study, researchers analyzed data from more than 8,200 women, aged 70 to 79, of European ancestry. The investigators found that genetic influences on body mass index (an estimate of body fat based on weight and height) were strongest in inactive... Read more

Motif Bio Submits NDA for Iclaprim

Posted 4 days ago in New Drug Applications

NEW YORK, June 14, 2018 (GLOBE NEWSWIRE) -- Motif Bio plc (AIM:MTFB) (NASDAQ:MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced the completion of its rolling submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for iclaprim, a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial... Read more

FDA Approves Moxidectin for the Treatment of River Blindness

Posted 4 days ago in New Drug Approvals

MELBOURNE, GENEVA, and NEW YORK - June 13, 2018 -- Medicines Development for Global Health (MDGH) and the World Health Organisation Special Programme for Research and Training in Tropical Diseases (TDR) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved moxidectin 8 mg oral for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older1. The FDA has... Read more

FDA Approves Genentech’s Avastin (bevacizumab) Plus Chemotherapy as a Treatment for Women With Advanced Ovarian Cancer Following Initial Surgery

Posted 5 days ago in New Drug Approvals

South San Francisco, CA -- June 13, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Avastin® (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical ... Read more

FDA Approves Keytruda (pembrolizumab) for Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

Posted 5 days ago in New Drug Approvals

KENILWORTH, N.J.--(BUSINESS WIRE) June 13, 2018 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, the company’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. ... Read more

FDA Approves Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1

Posted 5 days ago in New Drug Approvals

KENILWORTH, N.J.--(BUSINESS WIRE) June 12, 2018 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, the company’s anti-PD-1 therapy, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [Combined Positive Score (... Read more

Sunovion Announces FDA Acceptance of New Drug Application for Apomorphine Sublingual Film (APL-130277)

Posted 6 days ago in New Drug Applications

MARLBOROUGH, Mass.--(BUSINESS WIRE) June 12, 2018 --Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease (PD). The expected action date by the FDA under the Prescription Drug User F... Read more

Genentech Announces FDA Approval for Venclexta Plus Rituxan for People With Previously Treated Chronic Lymphocytic Leukemia

Posted 10 days ago in New Drug Approvals

South San Francisco, CA -- June 8, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Venclexta (venetoclax) in combination with Rituxan (rituximab) for the treatment of people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one... Read more

U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Talazoparib for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation

Posted 10 days ago in New Drug Applications

June 7, 2018 - Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib. The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or m... Read more

Intra-Cellular Therapies Initiates Rolling Submission of New Drug Application for Lumateperone for Treatment of Schizophrenia

Posted 12 days ago in New Drug Applications

NEW YORK, June 06, 2018 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced the initiation of a rolling submission of its New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for lumateperone for the treatment of schizophrenia. The Company plans to... Read more

Evoke Announces FDA Submission of New Drug Application for Gimoti

Posted 13 days ago in New Drug Applications

SOLANA BEACH, Calif., June 04, 2018 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced the submission of its 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Gimoti™, the Company’s nasal spray product candidate for the relief of symptoms in adult women with acute and r... Read more

Cytokinetics Announces Data From Phase 2 Clinical Study of Reldesemtiv in Patients With Spinal Muscular Atrophy

Posted 2 days ago in Clinical Trials

SOUTH SAN FRANCISCO, Calif., June 16, 2018 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq:CYTK) today announced data from the Phase 2 clinical study of reldesemtiv in patients with spinal muscular atrophy (SMA) were presented in an oral presentation by John W. Day, M.D., Ph.D., Professor of Neurology and Pediatrics (Genetics), Stanford University, at the 2018 Annual Cure SMA Conference in Dallas. This... Read more

Teva Provides Update on Clinical Trial of Fremanezumab for Use in Chronic Cluster Headache

Posted 3 days ago in Clinical Trials

JERUSALEM--(BUSINESS WIRE)--Jun. 15, 2018-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced a change in the clinical development program of fremanezumab in chronic cluster headache. The ENFORCE Phase III clinical development program includes a chronic cluster headache study, an episodic cluster headache study, and a long-term safety study. A pre-specified futility analysis of the chronic... Read more

Rhythm Pharmaceuticals Completes Pivotal Enrollment in Two Ongoing Phase 3 Clinical Trials Evaluating Setmelanotide in Rare Genetic Disorders of Obesity

Posted 4 days ago in Clinical Trials

BOSTON, June 14, 2018 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM), a biopharmaceutical company focused on the development and commercialization of therapeutics for the treatment of rare genetic disorders of obesity, today announced that it has completed enrollment of the pivotal cohorts of 10 patients in two separate, ongoing, registration-enabling Phase 3 clinical trials evaluating setmelanotide... Read more

Allergan's Oral CGRP Receptor Antagonist Atogepant Demonstrates Robust Efficacy and Safety in Episodic Migraine Prevention in a Phase 2b/3 Clinical Trial

Posted 7 days ago in Clinical Trials

DUBLIN, June 11, 2018 /PRNewswire/ -- Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, today announced positive results from CGP-MD-01, a Phase 2b/3 clinical trial evaluating the efficacy, safety, and tolerability of orally administered atogepant. All active treatment arms of atogepant met the primary endpoint across all doses and dose regimens, with a statistically significant reduction from... Read more

Paratek Presents New Analysis from Combined Phase 3 Skin Infection Studies Highlighting Efficacy of Omadacycline in Treating Drug Resistant S. aureus

Posted 7 days ago in Clinical Trials

BOSTON, June 11, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, presented a new analysis of combined data from the Company’s two, pivotal Phase 3 clinical studies of omadacycline in acute bacterial skin and skin structure infections (ABSSSI) when methicillin- (... Read more